NCT00987649

Ovarian Cancer Risk Estimation in Patients With Pelvic Mass

Evaluation of CA125 and HE4 Assays to Estimate the Risk of Ovarian Cancer in Patients Presenting to a General Surgeon or Obstetrician/Gynecologist With an Adnexal Mass

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 512 (actual)
• Sponsor: Fujirebio Diagnostics, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether the Risk of Ovarian Cancer Algorithm (ROMA) is effective in the determination of a woman's risk of cancer when she is scheduled to have surgery to remove a pelvic mass. After Informed Consent is obtained, an Initial Cancer Risk Assessment will be made. A blood sample will be collected within 30 days of the surgical procedure. Results of the surgical procedure will be collected and analyzed against the CA125 and HE4 results used in the calculation of the ROMA.

Conditions

• Adnexal Mass
• Ovarian Cancer

Timeline

• Start date: 2009-10-01
• Primary completion: 2010-08-01
• Completion: 2010-09-01
• First posted: 2009-10-01
• Last updated: 2011-02-09

Locations

13 sites across 1 country: United States